VITRAKVI 20 MGML ORAL SOLUTION

País: Israel

Idioma: inglés

Fuente: Ministry of Health

Ingredientes activos:

LAROTRECTINIB AS SULFATE

Disponible desde:

BAYER ISRAEL LTD

Código ATC:

L01XE53

formulario farmacéutico:

SOLUTION (ORAL)

Composición:

LAROTRECTINIB AS SULFATE 20 MG/ML

Vía de administración:

PER OS

tipo de receta:

Required

Fabricado por:

BAYER AG., GERMANY

Área terapéutica:

LAROTRECTINIB

indicaciones terapéuticas:

Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion,• Who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and• Who have no satisfactory treatment options

Fecha de autorización:

2020-04-19

Información para el usuario

PATIENT LEAFLET IN ACCORDANCE WITH THE
PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986
This medicine is dispensed with a doctor’s prescription only
VITRAKVI 20 MG/ML ORAL SOLUTION
ACTIVE INGREDIENT
Each ml contains 20 mg larotrectinib (as sulfate)
Inactive ingredients and allergens: See section 6 “Additional
information” and section 2 “Important information about some
of the ingredients of this medicine”.
READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. This leaflet contains concise information about this
medicine. If you have any further questions, consult your doctor
or pharmacist.
This medicine has been prescribed to treat your illness. Do not
pass it on to others. It may harm them, even if it seems to you
that their illness is similar to yours.
1. WHAT IS THIS MEDICINE INTENDED FOR?
Vitrakvi is a monotherapy intended to treat solid tumours
displaying NTRK (neurotrophic tyrosine receptor kinase) gene
fusion in adults and children.
Vitrakvi is administered when
- these tumours are locally advanced or have spread to other
parts of the body or if a surgery to remove the tumour is likely
to cause severe complications, and IN ADDITION
- there are no satisfactory treatment options.
Before you receive Vitrakvi, your doctor will perform a test to
check if you carry the change in the NTRK gene.
THERAPEUTIC GROUP:
Anti-neoplastic and immunomodulatory agents, anti-neoplastic
agents, protein kinase inhibitors
HOW VITRAKVI WORKS
In patients whose cancer is due to an altered NTRK gene, the
change in the gene causes the body to make an abnormal
protein called TRK fusion protein, which can lead to uncontrolled
cell growth and cancer. Vitrakvi blocks the activity of TRK fusion
proteins and so may slow or stop the growth of the cancerous
tumour. It may also help to shrink the cancerous tumour.
If you have any questions on how Vitrakvi works or why it has
been prescribed for you, ask your doctor, pharmacist or nurse.
2. BEFORE USING THIS MEDICINE
DO NOT USE THIS MEDICINE IF:
•
you are sensitiv

Ficha técnica

1
1.
NAME OF THE MEDICINAL PRODUCT
VITRAKVI 20 mg/mL oral solution
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of oral solution contains larotrectinib sulfate equivalent to
20 mg of larotrectinib.
Excipients with known effect:
Each mL of oral solution contains 2 mg sodium benzoate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution.
Colourless to yellow or orange or red or brownish solution.
4.
CLINICAL PARTICULARS
4.1
Therapeutic indications
VITRAKVI as monotherapy is indicated for the treatment of adult and
paediatric patients with solid
tumours that display a Neurotrophic Tyrosine Receptor Kinase (
_NTRK_
) gene fusion,
-
who have a disease that is locally advanced, metastatic or where
surgical resection is likely to
result in severe morbidity, and
-
who have no satisfactory treatment options (see sections 4.4 and 5.1).
4.2
Posology and method of administration
Treatment with VITRAKVI should be initiated by physicians experienced
in the administration of
anticancer therapies.
The presence of an
_NTRK_
gene fusion in a tumour specimen should be confirmed by a validated
test
prior to initiation of treatment with VITRAKVI.
Posology
_Adults _
The recommended dose in adults is 100 mg larotrectinib twice daily,
until disease progression or until
unacceptable toxicity occurs.
_ _
_Paediatric population _
Dosing in paediatric patients is based on body surface area (BSA). The
recommended dose in
paediatric patients is 100 mg/m
2
larotrectinib twice daily with a maximum of 100 mg per dose until
disease progression or until unacceptable toxicity occurs.
2
_Missed dose _
If a dose is missed, the patient should not take two doses at the same
time to make up for a missed
dose. Patients should take the next dose at the next scheduled time.
If the patient vomits after taking a
dose, the patient should not take an additional dose to make up for
vomiting.
_ _
_Dose modification _
For all Grade 2 adverse reactions, continued dosing may be
appropriate, though close monitoring to
ensure